Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis

NCT ID: NCT03054480

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2017-01-31

Brief Summary

Because of the limiting data about an efficacy and safety of fractional radiofrequency for the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and intradermal Botulinum toxin type A injection for the treatment of primary axillary hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's satisfaction and their quality of life by Dermatology Life Quality Index and side effect between the groups.

Conditions

Primary Axillary Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fractional Micro-Needle Radiofrequency

each patient will be treated with FMR DeAge®, applicator device at 4-week intervals for 2 sessions of treatment. This applicator consists of rows of 36 (6x6 needles) insulated microneedles that form an array of positively and negatively charged electrodes. The microneedles will deliver bipolar radiofrequency energy in a fractional manner that extends from 3.0 mm below the surface of the skin. All subjects will be prepared by local anesthesia to induce numbness at the axilla prior to treatment. The targeted axillary side will be treated with a total of 4 passes.

Group Type: EXPERIMENTAL

Fractional Micro-Needle Radiofrequency

Intervention Type: DEVICE

Botulinum toxin type A

50 units of Botulinum toxin type A will be intradermal injected over axillary area. The protocol by using 1-2 units per 1 injection area with the coverage of 1x1 cm2 will be treated.

Group Type: ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type: DRUG

Interventions

Fractional Micro-Needle Radiofrequency

Intervention Type: DEVICE

Botulinum toxin type A

Intervention Type: DRUG

Other Intervention Names

DeAgeEX Fractional RF; Neuronox

Eligibility Criteria

Inclusion Criteria

Male or female subjects, age between 18-60 years

• Healthy volunteers
• Subjects who have experienced with excessive sweating on both sides of axillary areas and have a positive result for iodine starch test on the screening day
• Willing to participant into the study and voluntary to sign in the informed consent form

Exclusion Criteria

Active bacterial or fungal infection over tested area / axillae

• Pregnancy and breast feeding
• Previously underwent the surgical treatment such as radical resection of sweat glands for primary axillary hyperhidrosis
• Currently being treated with intradermal botulinum toxin type A injection at axillary area for less than 12 months
• Currently being inserted the cardiac pace maker or any other internal electronic devices
• Secondary hyperhidrosis caused by hyperthyroidism, drug induced, abnormal autonomic or neurological disorder that affect sweat gland
• Allergy to botulinum toxin type A
• Known contact allergy to iodine
• Unable to follow and comply to the study protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mae Fah Luang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thep Chalermchai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

109/1-59

Identifier Type: -

Identifier Source: org_study_id